MAUDE Adverse Event Report: Merit Maquiladora Mexico One-Step¿; Catheter, Irrigation

Catalog Number	OSC-5F-10LT/B
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• Brand Name: One-Step¿
• Common Device Name: Catheter, Irrigation
• Manufacturer (Section D): Merit Maquiladora Mexico; avenida sor juana ines de; 19970 interior b, edificio 2; tijuana baja california 22630 ; MX 22630
• Manufacturer (Section G): Merit Maquiladora Mexico; avenida sor juana ines de; 19970 interior b, edificio 2; tijuana baja california 22630 ; MX 22630
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50677566
• Report Number: 3011642792-2026-00189
• Device Sequence Number: 20152935
• Product Code: GBX
• UDI-Device Identifier: 00884450092606
• UDI-Public: 00884450092606
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: OSC-5F-10LT/B
• Device Lot Number: I3249525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown